MAUDE Adverse Event Report: THERMIGEN LLC THERMIVA; THERMI RF ACCESSORIES

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Irritation (1941); Itching Sensation (1943); Pain (1994); Skin Tears (2516)

Event Date 04/03/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, i was treated with a thermiva for vulvar pain from cycling from (b)(6), a dermatologist group in (b)(6).In my consultation beforehand, i was counseled by a nurse practitioner and she deemed i was a candidate.She explained the laser would go both inside my vagina and on the outside vulvar area.I was clear that i did not have any issues with soreness or lubrication inside.I did report urine leakage at times and she said the internal treatment would help that condition.She said there were generally no side effects and no downtime.When i arrived at the appointment, the nurse practitioner was surprised i hadn't shaved my public area.I let her know that had never been mentioned.So she used her clipper and shaved me.When the laser was inside, i felt the warmth as i was told would happen.But when she used it on the exterior area, it was very hot, i complained and twice she had to stop an apply ice pack.Within a day, i developed intense vulvar pain, followed by itching.I needed to apply ice packs almost continually.I also applied a balm used to prevent cycle chafing.I called and discussed this with the nurse who said they had never seen these side effects and to continue to use ice.After about a week, i requested a follow up appointment with my dermatologist on (b)(6) 2017.She said the shaving with the clippers had caused micro tears in the skin tissue and the ointments were irritating it.She said to only use a neutral balm.To date, this condition has never properly healed.In the past year, i sought numerous treatments with some limited success.I tried a series of 12 acupuncture treatments, a series of pelvic pain physical therapies, a round of rx lyrical for nerve pain and multiple balms with thc, hemp and emu oil.I use the balms daily at this time.I have spent (b)(6) on treatments most not covered by insurance.And i cannot tolerate any touching of the area because of the tenderness.I have been unable to return to cycling because of soreness.When i am hot and when i exercise the situation worsens.My new gynecologist dr (b)(6) said that i should never have been treated with a laser for nerve pain from cycling.She said it just inflamed it further.To date, i have written to my dermatologist two detailed letter to let her know the long lasting side effects.Each time, i am told that their office or the manufacturer has had zero complaints of this type.When i saw the article in (b)(6) in later july 2018 about problems with thermiva and the fda, i decided to file a complaint.

• Brand Name: THERMIVA
• Type of Device: THERMI RF ACCESSORIES
• Manufacturer (Section D): THERMIGEN LLC
• MDR Report Key: 7784378
• MDR Text Key: 117301329
• Report Number: MW5079149
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 73